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A recent article by Ken Garber in Nature/Biotechnology, 27, 494 (June 2009) summarizes the recent Federal Circuit decision invalidating the claims-in-suit in Ariad v. Lilly for failure to meet the WDR. (See my post of April 13, 2009 “Federal Circuit Throws Wrench Into ‘Mechanism of Action Claims’” for a summary of the decision.) Various patent law “experts,” including this author, are quoted. Mr. Garber did a good job of summarizing the court’s position, but I don’t recall saying that affirming the validity of Ariad’s claims would be like “accepting a claim on anti-gravity.”

Under the Patent Office’s utility requirement guidelines (which I feel are unsupported by case law), an asserted utility must be specific, substantial, and credible. A claim to anti-gravity would surely fail the credibility test, but credibility of the asserted utilities was not an issue presented to the Federal Circuit. The utility of the ‘516 claims is manifest, at least if they are construed to be limited to the treatment of deleterious effects of elevated NF-kB, and many of them recite very specific utilities. However, this big “if” leads to another issue with these claims – are they even patentable subject matter?

In fact, the District Court found that the claims-in-suit were not unpatentable as “natural phenomena.” As you know if you have been reading my previous posts, I am very unsympathetic to infringement defenses asserting that claims cover “products of nature” or pre-empt all uses of “natural phenomena.” Usually, the hand of man is involved in diagnostic, screening or monitoring processes (or methods), even if “natural phenomena” or “products of nature” are being isolated, detected, or measured. However, one of the claims of the ‘516 patent considered by the district court in Ariad, reads as follows:

7. A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-kB-mediated intracellular signaling, the method comprising altering NF-kB activity in the cells such that NF-kB-mediated effects of external influences are modified. [529 F.Supp.2d at 115.]

Lilly argued that this claim, which does not recite administration of any exogenous drug, covers a natural process which the court referred to as “the autoregulatory loop” (regulating NF-kB levels in cells). The court reviewed the testimony and found that Lilly had not established by clear and convincing evidence that this natural process occurred in cells, but only that it might occur in vitro.

Lilly did not appeal this finding, but sorting through the scientific testimony summarized by the District Court, it looks like Lilly had a pretty strong argument that at least claim 7 encompasses a natural phenomenon, in the way that a method claim could encompass both the process of photosynthesis, a natural phenomenon, and an industrial process for making sugars from carbon dioxide, water, and radiation. If such a claim were valid, the patentee could collect royalties from every farmer or horticulturist, as well as from the Acme Sugar Company.


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